Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

NCT ID: NCT00006022

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.

Detailed Description

OBJECTIVES:

• Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma.
• Assess other intermediate markers of immune response in patients treated with this regimen.
• Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen.

OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.

Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.

Conditions

Kidney Cancer; Melanoma (Skin)

Keywords

stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer; stage III melanoma; stage IV melanoma; recurrent melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

bryostatin 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma

• Unresectable disease
• No known uncontrolled CNS metastases

• CNS metastases allowed only if recently irradiated or known to be controlled

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 8 g/dL
• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Absolute lymphocyte count at least 1,000/mm^3

Hepatic:

• Total bilirubin no greater than 1.5 mg/dL OR
• Conjugated bilirubin no greater than 0.3 mg/dL
• AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months
• No uncontrolled hypertension, angina, or congestive heart failure

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after study
• No known intolerance to acetaminophen
• No primary or secondary immunodeficiency
• No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 1 month since prior topical, systemic, or inhaled corticosteroids
• No concurrent topical, systemic, or inhaled corticosteroids

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Roberts, MD

Role: STUDY_CHAIR

Massey Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCV-MCC/CCHR-9910-2A

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0049

Identifier Type: -

Identifier Source: secondary_id

CDR0000068034

Identifier Type: -

Identifier Source: org_study_id